Effect of Exercise After Heart Transplantation

Heart Transplantation Clinical Trial

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Official title:

Effect of High Intensity Interval-based Aerobic Exercise 1-8 Years After Heart Transplantation. 1 Year Follow Up.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091194
• Other study ID #: 10920
• Status: Completed
• Phase: Phase 2
• First received: March 18, 2010
• Last updated: February 18, 2013
• Start date: October 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2013
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial which will include approximately 50 heart transplant recipients 1-8 years after heart transplantation. The intervention and follow up period is 1 year. The primary purpose is to investigate if systematic, high intensity, interval-based aerobic exercise training results in a greater improvement of exercise capacity (measured by VO2peak) than previously shown in heart transplant recipients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Norwegian heart transplanted patients > 18 years of age

• 1-8 years after heart transplantation

• Optimal medical treatment

• Stable condition

• Written informed consent

• Must have access to a physical therapist or personal trainer in their hometown

• Motivation for exercise

Exclusion Criteria:

• Unstable condition

• In need of revascularization or other invention

• Infections, open wounds or skin diseases

• Physical disabilities which prevent participation

• Other diseases, illnesses or conditions which contradict exercise

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

Other:
• Interval-based aerobic exercise
High intensity interval-based aerobic exercise training. Duration: 1 year. Three 8-weeks supervised periods of physical training 3 times per week. Individual training 2 times per week between these periods.

Locations

Country	Name	City	State
Norway	Department of Cardiology, Oslo University Hospital, Rikshospitalet	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Helse Sor-Ost

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Nytrøen K, Rustad LA, Aukrust P, Ueland T, Hallén J, Holm I, Rolid K, Lekva T, Fiane AE, Amlie JP, Aakhus S, Gullestad L. High-intensity interval training improves peak oxygen uptake and muscular exercise capacity in heart transplant recipients. Am J Tran — View Citation

Nytrøen K, Rustad LA, Gude E, Hallén J, Fiane AE, Rolid K, Holm I, Aakhus S, Gullestad L. Muscular exercise capacity and body fat predict VO(2peak) in heart transplant recipients. Eur J Prev Cardiol. 2014 Jan;21(1):21-9. doi: 10.1177/2047487312450540. Epu — View Citation

Rustad LA, Nytrøen K, Amundsen BH, Gullestad L, Aakhus S. One year of high-intensity interval training improves exercise capacity, but not left ventricular function in stable heart transplant recipients: a randomised controlled trial. Eur J Prev Cardiol. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak oxygen uptake (VO2peak)		Before and after the intervention period of 1 year	No
Secondary	Isokinetic muscle strength of quadriceps and hamstrings		Before and after the intervention period of 1 year	No
Secondary	Quality of life measured by questionnaires		Before and after the intervention period of 1 year	No
Secondary	Myocardial function measured by echocardiography		Before and after the intervention period of 1 year	No
Secondary	Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS)		Before and after the intervention period of 1 year	No
Secondary	Vascular tone and compliance measured by tonometry		Before and after the intervention period of 1 year	No
Secondary	Regular blood screening, lipid profile, inflammatory status, nerve growth factor, biochemical markers for endothelial function, prothrombotic factor, factors connected to vascularization: NT-proBNP and gene expression analysis.		Before and after the intervention period of 1 year	No
Secondary	Analysis of isolated muscle cells from myocardial biopsy		Before and after the intervention period of 1 year	No
Secondary	Reinnervation as judged by autonomic nervous control (Heart Rate Variability)		Before and after the intervention period of 1 year	No